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    Home > Active Ingredient News > Drugs Articles > Approval of new drugs by six major regulatory agencies in 2009-2018

    Approval of new drugs by six major regulatory agencies in 2009-2018

    • Last Update: 2019-07-15
    • Source: Internet
    • Author: User
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    The significant improvement of regulatory environment and the change of declaration strategy of multinational companies have reduced the time needed to obtain listing permission, improved the coordination and unity among the six regulators, and increased the number of new drugs approved for listing in the past 10 years (2009-2018), including the European Drug Administration (EMA), the us food and Drug Administration (FD) A) , Japan Pharmaceutical and medical devices Administration (PMDA), Health Canada, Swissmedic and TGA The International Center for regulatory science and innovation (CIRS) released a new study in the R & D briefing 70 entitled "new drugs approved by six major regulatory agencies in 2009-2018: focusing on accelerated review channels and orphan drug status" The study made statistics on the approval of new active substances (NAS) The findings are as follows The six regulatory agencies include the European Drug Administration (EMA), the US Food and Drug Administration (FDA), the Japanese drug and medical device administration (PMDA), the Canadian Ministry of health, Swissmedic and TGA (as shown in Figure 1) CIRS statistics show that the number of varieties approved by six regulators increased from 16 NAS in 2009-2013 to 52 NAS in 2014-2018, indicating that more products have achieved internationalization in this stage Potential influencing factors that affect the total time for new drug applications to be submitted and approved by regulatory agencies include company strategy, implementation and type of review procedures, product type and treatment area In particular, the accelerated review pathway (FRP), orphan drug designation and applicant size are the main factors influencing the submission and approval strategy Figure 1: improvement in the regulatory environment contributes to a general reduction in the time required to obtain a listing permit (approval time is the time between the submission of the application and the approval of the regulatory authority Time includes the time spent by regulators and applicants EMA approval time includes the time spent by the EU Committee )Source: the International Research Center for regulatory science and innovation is concerned that six regulators of the accelerated review channel have implemented a specific FRP, that is, the accelerated review process aimed at accelerating the review process of promising new active substances (referring to the "accelerated review" of EMA, the "green channel" of Swissmedic and the "priority review" of four other regulators) TGA has implemented the priority review system since 2017 and approved new drugs for the first time in 2018 Generally speaking, the time required to speed up the review process is shorter than the standard process In 2018, FDA (73%) accelerated review accounted for the highest proportion, followed by Health Canada (35%), PMDA (28%), Swissmedic (13%), EMA and TGA (10%) Among the six regulatory agencies, FDA provides (or can use) the most accelerated review channels (FRP) For areas that do not meet the medical needs, it can accelerate the review and / or approval of drugs and improve the accessibility of drugs In 2018, 75% of FDA approved NAS varieties benefited from at least one available FRP (excluding orphan drugs) Among other agencies, FRP benefits range from 10% of TGA to 41% of Health Canada (see Figure 2) Figure 2: among the regulatory agencies of the six countries, FDA provides (or can use) the most accelerated review channels (FRP) For areas with unmet medical needs, it can accelerate the review and / or approval of drugs and improve the accessibility of drugs Source: the number of NAS designated as orphan drug by the six regulatory agencies concerned about orphan drug status by the International Research Center for regulatory science and innovation increased from 25% in 2009-2013 to 38% in 2014-2018 In 2018, the FDA approved the most orphan drugs (35), while the PMDA was the least (8) Health Canada has not yet implemented the orphan drug policy; however, the agency approved 15 NAS designated as orphan drugs by FDA, EMA or TGA in 2018 In 2018, FDA's median approval time for orphan drugs was the shortest (243 days), because 88% of them were approved through accelerated review Of the six regulators, only EMA approved orphan drugs for more than non orphan drugs In 2018, these time indicators of Swissmedic are close Of the orphan drugs approved by TGA in 2018, 20% were approved through the priority review process just started Of the 52 NAS varieties approved by six regulators in 2014-2018, only 10 NAS varieties were designated as orphan drugs in all regulators, indicating that there are some differences in the standards of designated orphan drugs among regulators Generally speaking, the difference of median submission time of orphan drug NAS is longer than that of non orphan drug NAS In fact, most orphan drugs NAS are registered by non top enterprises, highlighting the important role of small-scale enterprises in promoting innovation Figure 3: CIRS statistics show that most orphan drug NAS are registered by non top enterprises, highlighting the important role of small-scale enterprises in promoting innovation Source: International Research Center for legal science innovation
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